Kornimate/medical-research-clean huggingface dataset:
methylprednisolone given by 24-hour or 48-hour infusion versus tirilazad for acute spinal cord injury

Conditions: Spinal Cord Injury

Summary: objectives: i. compare the efficacy and safety of 24- versus 48-hour infusion of methylprednisolone (meprdl) versus tirilazad for patients with acute spinal cord injury. ii. compare neurologic recovery following 24- and 48-hour meprdl infusions.

protocol outline: this is a randomized, double-blind study. patients are stratified by participating institution. patients are randomly assigned to 1 of 3 treatment groups within 6 hours of injury. treatment begins within 2 hours of randomization. one group receives a 24-hour methylprednisolone (meprdl) infusion: a loading dose followed in 45 minutes by a 23-hour continuous infusion. a placebo for tirilazad is also administered. a second group receives the same meprdl loading dose but the continuous infusion is maintained for 48 hours. a placebo for tirilazad is also administered. a third group receives a 48-hour infusion of tirilazad with an initial bolus dose of meprdl. eight additional doses of tirilazad are administered by intravenous push. the meprdl loading dose may be omitted for patients who received a prestudy meprdl dose. patients are followed at 72 hours, 6 weeks, 6 months, and 1 year after the injury.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- acute spinal cord injury; diagnosis confirmed by study physician using national acute spinal cord injury study neurologic exam glasgow coma score greater than 9 randomization within 6 hours of injury required; treatment must begin within 8 hours of injury no root involvement only; no cauda equina only --prior/concurrent therapy-- methylprednisolone bolus (20-40 mg/kg) prior to hospital admission allowed --patient characteristics-- hematopoietic: no hematologic contraindication to protocol therapy cardiovascular: no vascular contraindication to protocol therapy other: no diabetes; no gunshot wound; no gastrointestinal bleeding; no life-threatening co-morbidity; no other medical contraindication to protocol therapy; no pregnant women; no patients under indictment or incarcerated; no conditions that would complicate follow-up, e.g.: out-of-state residency or illegal alien status

Keywords: environmental/toxic disorders neurologic and psychiatric disorders rare disease spinal cord injury
a study in survivors of type b aortic dissection undergoing stenting

Conditions: Type B Aortic Dissection

Summary: cohort study according to national regulatory guidelines: non-interventional, observational cohort study. pair-matched comparison with patients chosen from historical series. to evaluate the clinical and technical success as well as the safety and feasibility of the e-xl aortic stent used in complicated type b aortic dissection in addition to a classic stentgraft in a single procedure.


Eligibility criteria:
the clinical records of the patients mus support the following criteria: * age \> 18 years * type b dissection with expanding false lumen eligible for endovascular treatment which occured within 90 days prior to implantation * the endovascular treatment may be associated with a complementary surgical operation * the total diameter of the dissected aortic segment should not surpass 6cm, and have increased between 0.5 and 1cm within 1 month, prior to implantation * visceral arteries involvement, i.e. perfusion of side branches via true or false lumen of type b dissection * aortic kinking \< 90° * the patient must be available for the appropriate follow-up times for the duration of the study * informed consent from patient or authorized relative the data of whose patients clinical records confirm one of the following conditions will not be considered in this study: * patients with a contraindication as indicated in the instruction for use * patients with chronic thrombocytopenia or ongoing anticoagulation * patients with renal failure and/or creatinine \>2.4mg/dl immediately before the intervention * patients in whom the false lumen is completely thrombosed * patients with ongoing infection * patients with ongoing cancer * patients who are enrolled in a clinical study * aortic landing zone diameter over 40 mm * potentially emboligenic iliac and aortic atheroma lesions * associated pathology with life expectancy of less than 24 months * unstable infectious syndrome

Keywords: type b dissection thoracic stentgraft aortic stent clinical and technical success safety and feasibility of e-xl aortic stent
chemotherapy options for the first line chemotherapy in elderly patient with advanced gastric cancer

Conditions: Gastric Cancer

Summary: the investigators compare the overall survival between combination chemotherapy and monochemotherapy as a first-line chemotherapy in elderly patients with metastatic or recurrent gastric cancer. the investigators also compare the progression free survival, response rate, safety, and, quality of life between two groups, and evaluate that the comprehensive geriatric assessment tested at baseline can predict the toxicity and compliance of treatment, survival of the patients.


Eligibility criteria:
inclusion criteria: * .metastatic or recurrent, histologically confirmed adenocarcinoma of stomach - previously untreated patients, including patients with previous adjuvant chemotherapy completed more than 6 months * 70 yrs or older * eastern cooperative oncology group 0-2 * measurable or evaluable disease * adequate major organ functions * hb ≥ 9.0 g/dl * white blood cell count ≥ 3000/μl * absolute neutrophil count (anc) ≥ 1500/μl \[\*anc = neutrophil segs ＋ neutrophil bands\] * platelet ≥ 100 × 103/ μl * total bilirubin ≤ 1.5 ×unl, aspartate aminotransferase (ast)/alanine aminotransferase (alt) ≤ 3.0x unl(in case of liver metastasis, ast/alt ≤ 5.0 x unl) * serum creatinine ≤ 1.5 × unl (in case of serum creatinine \> 1.5 mg/dl , ccr should be \>= 50 ml/min, ccr is calculated by cockcroft-gault or 24hr urine collection) * life expectancy \> 3month * written informed consent exclusion criteria: * metastatic or recurrent stomach cancer other than adenocarcinoma * her-2 positive * clinically significant, uncontrolled gastric outlet obstruction, bleeding, or perforation * radiation therapy within the previous 2wks * major surgery or trauma within the previous 4wks * other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix) * uncontrolled brain metastasis * presence of other serious disease (cardiovascular, hepatic, infection etc.) * patients who participated in other clinical trials within the previous 30days * men of childbearing potential not willing to use effective means of contraception

Keywords: gastric cancer, elderly, chemotherapy
a study about association between microbiome, metabolome and clinical characteristics in copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the goal of this observational registry study is to compare characteristics of gut and sputum microbiome and metabolome among copd patients with significant smoking history, copd patients without significant smoking history and healthy smoker. additionally, the investigators investigate the difference of blood metabolites and peripheral blood mononuclear cells level among groups. the main questions it aims to answer are: * are there significant difference in fecal or sputum microbiome and metabolome between copd patients and healthy smoker? * are there any distinct characteristics in microbiome and metabolome in copd with copd patients with significant smoking history, copd patients without significant smoking history compared with healthy smoker? * are there any difference in blood metabolites and peripheral blood mononuclear cells levels among patients with significant smoking history, copd patients without significant smoking history and healthy smoker * might distinct characteristics of microbiome and metabolites in copd patients be related to worse clinical outcomes in copd patients?


Eligibility criteria:
inclusion criteria: * copd patients, defined by fev1/fvc \<0.7, who * agree with informed consent * have no history of acute exacerbation within 3 months * healthy smoker without airflow limitation, defined by fev1/fvc ≥0.7, who * have smoking history with at least 30 pack-year * agree with informed consent * do not use medication for chronic respiratory disease exclusion criteria: * withdrawal of informed consent * history of acute exacerbation or antibiotics use within 3 months * difficulty to collect adequate stool, sputum and blood samples

Keywords: microbiome metabolome smoking history
pasimat: automatic measure of pasi

Conditions: Psoriasis

Summary: to quantify the severity of psoriasis in a consistent and clinically meaningful way is important in order to decide the therapeutic orientation to take for the patient. pasi (psoriasis area and severity index) scoring is recognised as gold standard for psoriasis assessment. the bodystudio atbm (automatic total body mapping) is a high-tech system performing standardized photos from head to feet and from all angles, which allows to map the entire skin covering all the human body in a few minutes.the primary objective of this study would be to evaluate the ability of the bodystudio atbm to calculate the pasi score of patients with psoriasis human body in a few minutes

psoriasis is a chronic inflammatory skin condition resulting in a significant impact on patients' quality of life. to quantify the severity of psoriasis in a consistent and clinically meaningful way is important in order to decide the therapeutic orientation to take for the patient. pasi (psoriasis area and severity index) scoring is recognised as gold standard for psoriasis assessment. however the measure of the pasi score is very complex. given this complexity, the pasi is influenced by inter and intra-rater variation. in addition the pasi assessment process is time consuming. the bodystudio atbm (automatic total body mapping) is a high-tech system performing standardized photos from head to feet and from all angles, which allows to map the entire skin covering all the human body in a few minutes. the mapping of the entire body is automatically done by the use of a digital camera performing 20 pictures of the patient with 8 successive positions. the system is coupled to a software of automatic analysis of these pictures for the measure of the pasi score. the primary objective of this study would be to evaluate the ability of the bodystudio atbm to calculate the pasi score of patients with psoriasis

Eligibility criteria:
inclusion criteria: * age \>= 18 years old * subject is affiliated to a national health system at screening visit * understand and sign an informed consent form (icf) at screening, prior to any investigational procedures being performed. * patient with moderate to severe plaque psoriasis. * the patient is willing and able to be evaluated by the bodystudio atbm: 3 minutes for a young patient and until 7 minutes for an oldest. * the patient is able to staying up during all the total body mapping procedure exclusion criteria: * the subject is vulnerable (such as deprived from freedom) as defined in section 1.61 of international conference on harmonisation (ich) guideline for good clinical practice (gcp). * pregnant woman or who are breast-feeding * patient with tattoos that could influence the pasi assessment. * patient with skin type (phototype) v or iv according to fitzpatrick classification * male patients with exceeding facial or skin hair that could influence the automatic pasi assessment. * patients with exceeding varicose veins. * patients with sun burn
health care seeking behavior and knowledge assessment of hungarian women about pelvic floor disorders

Conditions: Urinary Incontinence; Pelvic Organ Prolapse; Knowledge, Attitudes, Practice; Behavior, Health

Summary: the aim of this study is to assess women's health care seeking behavior and knowledge of urinary incontinence and pelvic organ prolapse and to culturally adapt the prolapse and incontinence knowledge questionnaire (pikq) for the hungarian population.


Eligibility criteria:
inclusion criteria: * woman * age 18 and above * ability to read and write hungarian * willing to complete the online survey * providing consent to participate exclusion criteria: * respondents who had already completed the questionnaire on a prior occasion * respondents who unable to complete the online survey due to illiteracy
a phase ii trial of induction chemotherapy with nd-420, cisplatin and fluorouracil followed by surgery in the treatment of patients with localized squamous cell carcinoma of the esophagus

Conditions: Localized Squamous Cell Carcinoma of the Esophagus

Summary: investigator will assign 53 patients who had been histologically proven localized squamous cell carcinoma of esophagus to receive the induction chemotherapy regimen of nd-420 50 mg/m2 on day 1, cisplatin 70 mg/m2 on day1, plus fluorouracil 700 mg/m2 daily, day1 to day4, every 3 weeks for 2 cycles and then followed by surgical resection. the successful rate of complete treatment per protocol and complete resection will be the primary variant to evaluate in our study.


Eligibility criteria:
inclusion criteria: * patients must have been histologically proven esophageal carcinoma (squamous cell carcinoma). * the tumor had to be locally advanced (stage t2-3/n0, t1-3/n+, if technically resectable with curative intent). * patients must be 20 years of age. * patients must have an ecog performance status score 2. * patients must have a life expectancy of at least 12 weeks. * patients must be accessible for treatment and follow-up at least for one year. * patients must sign the informed consent form. * patient must have:hemoglobin level 9 g/dl; neutrophil count 1,500/mm3; platelets count 100,000/mm3; serum bilirubin level 1.0 uln; serum transaminase (got, gpt) levels 2.0 uln; serum alkaline phosphatase levels 2.0 uln; serum creatinine level 1.5 mg/dl or creatinine clearance rate(crcl)60 ml/min for the institution (calculated by the cockcroft- gault equation). exclusion criteria: * patient who are receiving or had received concurrent radiotherapy, chemotherapy or other anticancer treatment for esophageal carcinoma. * patients with known history of severe hypersensitivity reactions to any medicine or to drugs formulated with polysorbate 80. * major surgery within two weeks prior to entering the study, excluding port-a insertion or feeding jejunostomy surgery. * patients with cns metastasis, including clinical suspicion. * patients with clinically detectable peripheral neuropathy 2 on the ctc criteria. * mental statuses of patients are not fit for clinical trial. * fertile men and women unless using a reliable and appropriate contraceptive method. * patients with pregnancy or lactating, women considering pregnancy, possible pregnancy that without using effective contraception. * patients who have serious concomitant illness that might be aggravated by chemotherapy, as below included:active cardiac disease (e.g. congestive heart failure, angina, arrhythmia, acute myocardial disease or other types of heart disease requiring treatment) within 6 months period preceding entry into the study; uncontrolled infection (e.g. active infection that uncontrolled for 2 weeks under antibiotic therapy); retention of body fluid (e.g. pleural effusion, ascites, pericardial effusion, and edema needing treatment); history of other than esophageal cancer, except curatively treated non-melanoma skin cancer or in situ carcinoma of the esophagus; and other conditions which will be judged by physician's discretion.
unexplained recurrent pregnancy loss: new therapeutic perspectives

Conditions: Miscarriage, Recurrent

Summary: evaluation of gut permeability and endometrial inflammasome nlrp3 in women with unexplaid recurrent pregnancy loss before-after administration of bifidobacteriumlongum es1.


Eligibility criteria:
inclusion criteria: * idiopathic recurrent pregnancy loss * genetic predisposition to celiac disease exclusion criteria: -

Keywords: recurrent pregnancy loss
to evaluate anti-adhesive effect and safety of a mixed solid of poloxamer, gelatin and chitosan(mediclore®)

Conditions: Gynecologic Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of mediclore®, as an antiadhesive barrier, which is made of poloxamer, gelatin and chitosan.

to evaluate the efficacy and safety of mediclore®, as an antiadhesive barrier

Eligibility criteria:
inclusion criteria: * the patients with submucosal myomas, endometrial polyps, intra-uterine adhesion, uterine septa, dysfunctional uterine bleeding * written informed consent * patients without clinically significant lab exclusion criteria: * having enrolled another clinical trials within 1 month * immunosuppression or autoimmune disease * anticoagulant, general steroids within a week from surgery * incompatible medications * serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
mind-body wellness intervention in primary biliary cholangitis (pbc)

Conditions: Primary Biliary Cirrhosis

Summary: the investigators have designed a guided, online, multicomponent, mind-body intervention for participants with primary biliary cholangitis. the ability of the online intervention to impact the primary and secondary outcome measures will be assessed as compared to control.

persons with primary biliary cholangitis (pbc) experience significantly higher rates of fatigue, stress, anxiety, depression, and impaired health related quality of life (hrqol) as compared to the general population. online wellness programming ranging from physical activity to mindfulness interventions has been shown to be effective in decreasing fatigue and improving mental wellness in a variety of chronic disease populations. to date, no large-scale studies have been conducted to discern whether programming of this nature impacts measures of wellbeing in pbc. building upon a 12-week, online, mind-body wellness program that our team previously co-developed with the canadian pbc society and launched as a feasibility and acceptability trial to a group of 30 individuals with pbc, the primary aim of this research project is to carry out a randomized controlled trial to assess the efficacy of the online intervention provided with brief study follow-up phone calls performed weekly by study personnel as compared to a control arm. the ability of the online program to impact the primary outcome measure of anxiety and depression as measured by the hospital anxiety and depression scale (hads), and a range of secondary outcomes including perceived stress, fatigue, resilience, health related quality of life, physical functioning will be assessed as compared to control.

Eligibility criteria:
inclusion criteria: * adults (≥ 18 years) * identified diagnosis of pbc * ability to communicate (read, write, speak) in english * access to an internet connected device at home. exclusion criteria: * inability to provide informed consent * unsafe to participate in a low-intensity online activity program (e.g. uncontrolled angina or arrhythmia, myocardial infarction or stroke within the last 3 month, other major medical comorbidity of concern) * severe psychiatric disorders (hads score \>10)

Keywords: mind body therapy yoga meditation behavior change fatigue quality of life stress depression anxiety
colour coded duplex ultrasound of native arterio-venous fistula for haemodialysis with venous pressure measurement using controlled compression ultrasound as a predictor for shunt maturation in the early postoperative phase

Conditions: Renal Insufficiency

Summary: prospective observational ultrasound study of native arterio-venous fistula for haemodialysis with venous pressure measurement using controlled compression ultrasound.


Eligibility criteria:
inclusion criteria: * patients after creation of a native arterio-venous fistula at the cephalic vein for hemodialysis access; * informed consent. exclusion criteria: * former creation of a native arterio-venous fistula at the same arm; * known upper extremity occlusive arterial disease; * situation when ultrasound examination is not suitable: extreme swelling of the arm, post-operative pain, hematoma, local infections.
study of the in vivo expression of mu opioid receptors using pet and the selective tracer [c-11] carfentanil in normal weight and obese subjects

Conditions: Nuclear Medicine

Summary: positron emission tomography (pet) is a nuclear medicine technique that allows the measurement, in vivo in humans, with a non-invasive method, of the regional distribution of substances marked with positron emission isotopes such as c-11, in different districts bodily. using this method it is therefore possible to directly measure at the level of the brain the distribution of receptors, enzymes, reuptake sites, as well as their interaction with various classes of drugs and the related modifications that may be present during the pathology. the evaluation of the endogenous opiate receptor system will be implemented by comparing the in vivo binding maps of 11c carfentanil in the two groups of subjects under examination (normal weight, nor and obese, ob, based on body mass index, bmi); in fact, experimental data deriving from previous studies support the hypothesis that the basis of obesity and incorrect eating behaviors is a dysregulation of the endogenous ligand-mu opioid receptor interaction. the comparison of the data deriving from the analysis of the pet exams performed on the two groups of subjects will therefore allow us to evaluate the alterations of the opioid system possibly present in obese subjects.


Eligibility criteria:
inclusion criteria: * aged between 18 and 40 years; * structured sports activity \< 2 hours per week exclusion criteria: * drug allergy; * clinical evidence of neuropsychiatric pathologies.
somatosensory evoked potentials and pain thresholds in term and preterm-born adolescents after early exposure to pain; a quantitative study

Conditions: Somatosensory Disorders

Summary: background: several studies have indicated that infants who had undergone postnatal painful procedures appear to be hypersensitive to pain, with a lower threshold to tactile stimulations later on life. objective: to study the effect of early exposure to pain on cerebral somatosensory evoked potential (sep) response to thermal stimulation (550c), in preterm and full term born adolescents (15-18 years old), who have undergone painful procedures during their neonatal period. as well as to study the effect of early exposure to thermal and tactile sensory thresholds and pain thresholds to thermal and tactile stimuli, by using the tsa and von frey hairs. design: case-control study. participants: four groups of 20 adolescents (aged 15-18 years), two of which are full term and preterm-born who were exposed to painful procedures during the neonatal period. the other two groups are term and preterm-born adolescents who were not exposed to such procedures. main outcome measures: cerebral sep response (p300, medoc ltd., israel) to thermal stimulation (550c). warm-sensation threshold (wst), heat-pain threshold (hpt), cold sensation threshold (cst) and cold pain threshold (cpt) by using thermal sensory analyzer (tsa-2001,medoc ltd., israel). pain threshold to tactile stimulation will be measured by using von-frey hairs.


Eligibility criteria:
inclusion criteria: for all: * age 15-18 * appropriate weight for gestational age (aga) * informed consent signed by the parent * presence of one parent during the examination premature groups: * preterm-born (32-34 weeks of gestation) * admitted to the nicu (ventilated vs. non-ventilated) full term groups: * completed 37 weeks of gestation pain groups (premature and full term) * admitted to the nicu * mechanically-ventilated during the first week of life * mechanically-ventilated for at least 48 hours exclusion criteria: * current use of analgesia * a chronic illness with current medical treatment * cognitive impairment

Keywords: pain preterm-born adolescents